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Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery

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ClinicalTrials.gov Identifier: NCT01297803
Recruitment Status : Unknown
Verified November 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 17, 2011
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.

Condition or disease Intervention/treatment Phase
Glaucoma Patients Scheduled for Trabeculectomy Drug: Mitomycin_c Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
Study Start Date : November 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mitomycin_c application before sclera flap dissection Drug: Mitomycin_c
0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection

Active Comparator: Mitomycin_c application after sclera flapdissection Drug: Mitomycin_c
0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection




Primary Outcome Measures :
  1. corneal endothelial cell density [ Time Frame: six month ]
    specular microscopy

  2. corneal endothelial cell polymorphism [ Time Frame: 6 months ]
    specular microscopy

  3. corneal endothelial cell polymegathism [ Time Frame: 6 months ]
    specular microscopy


Secondary Outcome Measures :
  1. IOP (intra ocular pressure) [ Time Frame: six months ]
    applanation tonometry



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age Range between 18 to 80 years old
  • Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion Criteria:

  • Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297803


Locations
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Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: shahin Yazdani    00982122585952    labbafi@hotmail.com   
Principal Investigator: shahin yazdani         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Shahin Yazdani, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01297803    
Other Study ID Numbers: 8772
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: November 2010
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors